Abstract 154: A Comparison of Carotid Artery Stent Placement Performed Within and Outside Clinical Trials in the United States

Background: A discrepancy between characteristics of patients treated with carotid angioplasty and stent placement (CAS) within and outside clinical trials, particularly characteristics with direct impact on clinical outcome, may lead to reduction in anticipated benefit. Objective: To identify differences in demographic and clinical characteristics and outcomes related to CAS in patients treated within clinical trials and those treated outside clinical trials in a large national cohort. Methods: We determined the frequency of CAS performed within and outside clinical trials and associated in-hospital outcomes using data from the Nationwide Inpatient Survey (NIS) data files from 2005 to 2008. All the in-hospital outcomes were analyzed after adjusting for potential confounders using multivariate analysis. Results: Of the 47,899 patients who underwent CAS, 16,078 (1%) underwent the procedure as part of a clinical trial. The mean age of the patients was significantly lower in patients treated with CAS as part of a clinical trial than those treated with CAS outside a clinical trial. The proportion of women and non-whites was lower among patients treated with CAS as part of a clinical trial. The in-hospital mortality was two folds higher among patients treated with CAS outside clinical trial (1.12% versus 0.53%, p=0.0.0005). The rate of composite end-point of stroke, cardiac events, and death was significantly higher among patients treated with CAS outside clinical trials (p=0.02). After adjusting for age, gender, presence of hypertension, diabetes mellitus, renal failure, congestive heart failure, and hospital teaching status, CAS performed as part of clinical trial was associated with lower rates of in-hospital mortality (OR 0.349, 95% CI 0.219-0.555)(p<0.0001) and composite end point of stroke, cardiac events, and death (OR 0.349, 95% CI 0.219-0.555)(p<0.0001) . Conclusions: Our results suggests that CAS performed as part of clinical trial was associated with lower rates of in-hospital mortality and composite end point of stroke, cardiac events, and death in United States. These findings highlight the need for strategies that ensure appropriate adoption of CAS to ensure that the benefits observed in clinical trials can be replicated in general practice.

Download Full-text

Distribution and geographic accessibility of prostate cancer clinical trials in the United States.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.4_suppl.59 ◽

2014 ◽

Vol 32 (4_suppl) ◽

pp. 59-59 ◽

Cited By ~ 2

Author(s):

Matt D. Galsky ◽

Asma Latif ◽

Kristian D. Stensland ◽

Erin L. Moshier ◽

Russell McBride ◽

...

Keyword(s):

Prostate Cancer ◽

United States ◽

Clinical Trial ◽

Clinical Trials ◽

Geographic Distribution ◽

The United States ◽

First Line ◽

Trial Site ◽

Lorenz Curves ◽

Number Of Patients

59 Background: An extremely small proportion of patients with cancer in the United States (US) enroll in clinical trials. While several barriers to trial accrual have been described, the geographic distribution and accessibility of clinical trial sites has not been comprehensively explored. Methods: ClinicalTrials.gov was queried to identify all active US clinical trials exploring first-line therapies for metastatic prostate cancer (PCa) on 9/16/2012. We evaluated the geographic distribution of trial sites and determined the relationship between the number of sites and the number of patients with advanced PCa per county and evaluated heterogeneity using Lorenz curves. We also estimated the minimum driving distance required to access a clinical trial site from each ZIP code in the continguous US; a distance >30 miles was defined as high travel burden consistent with prior studies. Results: We identified 958 sites associated with 42 PCa clinical trials (Table). The geographic distribution of clinical trial sites was very inhomogeneous with several states having only 1-2 trial sites. Among 3185 US counties, 2,669 (83.8%) had no clinical trials available for first-line treatment of metastatic PCa. Counties with larger populations of patients with advanced PCa had significantly higher numbers of clinical trial sites. For every 100 additional patients with advanced PCa per county, the number of available trial sites increased by 21.0% (95% CI: 16.5-25.7%). However, Lorenz curves indicated a high degree of inequality in trial accessibility (Gini index 0.71). Approximately 31% of the US population resided >30 miles from a PCa trial site. Conclusions: Clinical trials sites are poorly accessible, geographically, to a large subset of US PCa patients, a finding that likely contributes to dismal accrual. Innovative solutions are required to address geographic barriers to access. [Table: see text]

Download Full-text

A Comparison of Carotid Artery Stent Placement Performed within and outside Clinical Trials in the United States (IN2-1.007)

Neurology ◽

10.1212/wnl.78.1_meetingabstracts.in2-1.007 ◽

2012 ◽

Vol 78 (Meeting Abstracts 1) ◽

pp. IN2-1.007-IN2-1.007

Author(s):

H. Hussein ◽

S. Chaudhry ◽

R. Khatri ◽

S. Majidi ◽

G. Rodriguez ◽

...

Keyword(s):

United States ◽

Clinical Trials ◽

Carotid Artery ◽

Stent Placement ◽

The United States ◽

Carotid Artery Stent

Download Full-text

An Investigation into the Therapeutic Action of Hydroxyzine (Atarax) in the Treatment of Nervous Disorders and the Control of the Tobacco-Habit

Journal of Mental Science ◽

10.1192/bjp.104.436.826 ◽

1958 ◽

Vol 104 (436) ◽

pp. 826-833 ◽

Cited By ~ 7

Author(s):

G. C. Turle

Keyword(s):

United States ◽

Clinical Trial ◽

Clinical Trials ◽

Side Effects ◽

Young Children ◽

Mental Hospital ◽

The United States ◽

Child Guidance Clinic ◽

Therapeutic Action ◽

Child Guidance

Hydroxyzine hydrochloride (Atarax, UCB 4492) is a tranquillizer which has attracted much interest in the United States, where it has undergone a series of clinical trials with encouraging results. In order to test the claims of American investigators a trial of hydroxyzine was made on a group of psychotic and psychoneurotic patients in a large mental hospital. The effectiveness of hydroxyzine in controlling the tobacco habit was also tested by using volunteer nurses at the hospital. Their observations provided useful information on the subjective action and side effects of the drug. A small number of young children attending a local child guidance clinic were also included in the clinical trial.

Download Full-text

Disparity in Clinical Trial Opportunities for Patients with B-Cell Malignancies in the United States

Blood ◽

10.1182/blood-2018-99-117155 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 4861-4861

Author(s):

Sikander Ailawadhi ◽

Sri Lekha Bodepudi ◽

Zan Tahir Shareef ◽

Fabiola Coromoto Cardozo ◽

Salman Ahmed ◽

...

Keyword(s):

United States ◽

Clinical Trial ◽

Clinical Trials ◽

Geographical Distribution ◽

Research Funding ◽

Phase 1 ◽

The United States ◽

Phase 2 ◽

B Cell Malignancies ◽

The Us

Abstract Background: Clinical trials are fundamental to advance therapeutics systematically and improve patient outcomes. Despite this, enrollment on clinical trials remains dismal in the United States (US) and is a constant focus of healthcare policy. We studied distribution of clinical trials for B-cell malignancies over time across the US and unique clinical trial opportunities i.e. individual clinical trials for the given diagnosis at a site that patients may have access to participate. Methods: We abstracted data from clinicaltrials.gov for all trials that had non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) as an inclusion indication between 1999-2018. Clinical trial characteristics and distribution over US geographical divisions (West, Midwest, Northeast, and South) were studied, and differences were assessed by Chi-square test. Results: A total of 1930 trials were identified (NHL: 982, MM: 948), of which 483 were recruiting at the time of data abstraction (NHL: 250, MM: 233). Over the past 2 decades, 182691 patients were enrolled on the various trials (NHL: 81592, MM: 101099). Trials by phase of study included phase 1: 629, phase 1/2: 316, phase 2: 813, phase 2/3: 11 and phase 3: 161. Number of trials by phase separated by NHL and MM are shown in Figure 1. Of these, 197 trials were randomized (NHL: 67, MM: 130). Geographical distribution of trials by diagnosis type is shown in Figure 2. A total of 31806 unique trial opportunities were noted for MM and NHL, of which 9,513 were international and 22,293 were in the US, with a geographical distribution of 5080 in West, 8198 in Midwest, 3944 in Northeast, and 5071 in South. 4,883 of the unique trial opportunities were available at NCI/NCCN accredited sites and 17,410 were at non-NCI/NCCN sites in the US. Treatment characteristics of the trials included monoclonal antibodies in 1218, other targeted agents in 2641, stem cell transplant in 526, and other agents in 517 trials with several trials utilizing more than one of these therapeutic options. There was no statistically significant difference in the distribution of clinical trials by phase of study across various US geographical regions for MM (p=0.71), NHL (p=0.98) or combined MM+NHL (p=0.16). On the other hand, unique trial opportunities were significantly different by study phase and geographical distribution for MM, NHL or MM+NHL (all p<0.001) (Figure 3). Conclusions: Widespread access to clinical trials within a cancer diagnosis is imperative for generalizability of trial results. In a comprehensive, national analysis we noted that while it may appear that clinical trials are available across the US, sites where they are open are distributed unevenly, giving rise to a disparity in access to evidence-based therapeutic advancements for patients. Disclosures Ailawadhi: Janssen: Consultancy; Amgen: Consultancy; Pharmacyclics: Research Funding; Takeda: Consultancy; Celgene: Consultancy. Sher:Affimed: Research Funding.

Download Full-text

Prevalence and Inpatient Hospital Outcomes of Malignancy-Related Ascites in the United States

American Journal of Hospice and Palliative Medicine® ◽

10.1177/1049909120928980 ◽

2020 ◽

Vol 38 (1) ◽

pp. 47-53

Author(s):

Venkataraghavan Ramamoorthy ◽

Muni Rubens ◽

Anshul Saxena ◽

Chintan Bhatt ◽

Sankalp Das ◽

...

Keyword(s):

United States ◽

Length Of Stay ◽

Hospital Mortality ◽

The United States ◽

Hospital Length ◽

Hospital Length Of Stay ◽

National Database ◽

Hospital Outcomes ◽

Inpatient Hospital ◽

Male Sex

Objective: Malignancy-related ascites (MRA) is the terminal stage of many advanced cancers, and the treatment is mainly palliative. This study looked for epidemiology and inpatient hospital outcomes of patients with MRA in the United States using a national database. Methods: The current study was a cross-sectional analysis of 2015 National Inpatient Sample data and consisted of patients ≥18 years with MRA. Descriptive statistics were used for understanding demographics, clinical characteristics, and MRA hospitalization costs. Multivariate regression models were used to identify predictors of length of hospital stay and in-hospital mortality. Results: There were 123 410 MRA hospitalizations in 2015. The median length of stay was 4.7 days (interquartile range [IQR]: 2.5-8.6 days), median cost of hospitalization was US$43 543 (IQR: US$23 485-US$82 248), and in-hospital mortality rate was 8.8% (n = 10 855). Multivariate analyses showed that male sex, black race, and admission to medium and large hospitals were associated with increased hospital length of stay. Factors associated with higher in-hospital mortality rates included male sex; Asian or Pacific Islander race; beneficiaries of private insurance, Medicaid, and self-pay; patients residing in large central and small metro counties; nonelective admission type; and rural and urban nonteaching hospitals. Conclusions: Our study showed that many demographic, socioeconomic, health care, and geographic factors were associated with hospital length of stay and in-hospital mortality and may suggest disparities in quality of care. These factors could be targeted for preventing unplanned hospitalization, decreasing hospital length of stay, and lowering in-hospital mortality for this population.

Download Full-text

CHARACTERISTICS OF NONTRAUMATIC SUBARACHNOID HEMORRHAGE IN THE UNITED STATES IN 2003

Neurosurgery ◽

10.1227/01.neu.0000306090.30517.ae ◽

2007 ◽

Vol 61 (6) ◽

pp. 1131-1138 ◽

Cited By ~ 71

Author(s):

Alisa M. Shea ◽

Shelby D. Reed ◽

Lesley H. Curtis ◽

Michael J. Alexander ◽

John J. Villani ◽

...

Keyword(s):

United States ◽

Subarachnoid Hemorrhage ◽

Mortality Rate ◽

Confidence Interval ◽

Hospital Mortality ◽

Odds Ratio ◽

The United States ◽

National Database ◽

Endovascular Coiling ◽

Hospital Outcomes

Abstract OBJECTIVE Substantial progress has been made in the diagnosis and treatment of subarachnoid hemorrhage (SAH). However, studies of SAH in the United States do not include information more recent than 2001, precluding analysis of shifts in treatment methods. We examined the epidemiology and in-hospital outcomes of nontraumatic SAH in the United States. METHODS We analyzed nationally representative data from the 2003 Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project to determine demographic and hospital characteristics, treatments, and in-hospital outcomes of patients with nontraumatic SAH. RESULTS In 2003, there were an estimated 31,476 discharges for nontraumatic SAH among patients aged 17 years or older, or 14.5 discharges per 100,000 adults. The in-hospital mortality rate was 25.3%. Microvascular clipping was performed in 7513 discharges, or 23.9% of inpatients with nontraumatic SAH; endovascular coiling was performed in 2849 discharges (9.1%). Adjusted odds of treatment with either procedure were significantly higher in urban teaching hospitals compared with urban nonteaching hospitals (odds ratio, 1.62; 95% confidence interval, 1.00–2.62) or rural hospitals (odds ratio, 3.08; 95% confidence interval, 1.93–4.91). CONCLUSION The in-hospital mortality rate associated with nontraumatic SAH continues to exceed 25%. Although it is unclear how many patients with nontraumatic SAH were actually diagnosed with a cerebral aneurysm, this study suggests that less than one-third of patients hospitalized for SAH receive surgical or endovascular treatment. Prospective studies are needed to elucidate either what systematic coding error is occurring in the national database or why patients may not receive treatment to secure a ruptured aneurysm.

Download Full-text

Clinical Trial Metrics: The Complexity of Conducting Clinical Trials in North American Cancer Centers

JCO Oncology Practice ◽

10.1200/op.20.00501 ◽

2020 ◽

pp. OP.20.00501

Author(s):

Carrie Lee ◽

Theresa L. Werner ◽

Allison M. Deal ◽

Cassandra J. Krise-Confair ◽

Tricia Adrales Bentz ◽

...

Keyword(s):

United States ◽

Clinical Trial ◽

Clinical Trials ◽

North America ◽

Clinical Research ◽

The United States ◽

Median Number ◽

Steering Committee ◽

Full Time ◽

Cancer Centers

PURPOSE: Cancer clinical trials offices (CTOs) support the investigation of cancer prevention, early detection, and treatment at cancer centers across North America. CTOs are a centralized resource for clinical trial conduct and typically use research staff with expertise in four functional areas of clinical research: finance, regulatory, clinical, and data operations. To our knowledge, there are no publicly available benchmark data sets that characterize the size, cost, volume, and efficiency of these offices, nor whether the metrics differ by National Cancer Institute (NCI) designation. The Association of American Cancer Institutes (AACI) Clinical Research Innovation (CRI) steering committee developed a survey to address this knowledge gap. METHODS: An 11-question survey that addressed CTO budget, accrual and trial volume, full-time equivalents (FTEs), staff turnover, and activation timelines was developed by the AACI CRI steering committee and sent to 92 academic cancer research centers in North America (n = 90 in the United States; n = 2 in Canada), with 79 respondents completing the survey (86% completion rate). RESULTS: The number of FTE employees working in the CTOs ranged from 4.5 to 811 (median, 104). The median number of analytic cases (ie, newly diagnosed or received first course of treatment) reported by the main center was 3,856. Annual CTO budgets ranged from $250,000 to $23,900,000 (median, $8.2 million). The median trial activation time, based on 61 centers, was 167 days. The median number of accruals per center was 480 (range, 5-6,271) and median number of trials per center was 282 (range, 31-1,833). Budget and FTE ranges varied by NCI designation. CONCLUSION: The response rate to the survey was high. These data will allow cancer centers to evaluate their CTO infrastructure, funding, portfolio, and/or accrual goals as compared with peers. A wide range in each of the outcomes was noted, in keeping with the wide variation in size and scope of cancer center CTOs across the United States and Canada. These variations may warrant additional investigation.

Download Full-text